Sr Quality Engineer

Pay 50-60/h depending on experience

1. Design Control and Regulatory Experience (ISO 13485, 21 CFR 820, EU-MDR, MDD)

2. Risk Management and Validation Proficiency

3. Implantable / Electro-Mechanical Device Experience

Seeking a highly experienced Quality Engineer to provide crucial quality engineering support throughout the product development lifecycle for complex implantable / electro-mechanical medical devices. The ideal candidate will possess detailed knowledge of FDA 21CFR 820, ISO 13485, and ISO 14971 to ensure full compliance with design control principles and global medical device regulations like EU-MDR. This role demands serving as a Subject Matter Expert for Risk Management (Hazards Analysis, FMEAs), leading design verification and validation testing, and executing process validations (TMV, IQ/OQ/PQ). Furthermore, the role involves supporting design transfer, supplier qualifications, continuous improvement initiatives, and utilizing sound problem-solving methodologies to resolve quality issues, requiring the ability to author comprehensive technical documentation.

Education Required: Bachelor’s degree in engineering or science with 5+ years of work experience in Quality and/or Engineering OR master’s degree in engineering or science with 3+ years of work experience in Quality and/or Engineering

Years’ Experience Required: Minimum 3 years of work experience

Will the contractor be working 40 hours a week? If not, weekly estimate?Yes, 40hrs / week

Work Location:

Do they need to be local to any MDT office and if so where?Yes, shuttle between Northridge, CA and Moorpark, CA on different days based on work

Does this person need to be on site? If so, full time or part time?Yes, Full-time on-site

A Day in the Life
As a Sr. Hardware Design Assurance Engineer, you will leverage your deep expertise in hardware quality engineering to support the development of medical devices from a pre-market perspective. This role focuses on ensuring compliance with regulatory standards and delivering high-quality hardware solutions through collaboration with cross-functional teams.
Essential Functions and Responsibilities
· Provide quality engineering support throughout the product development lifecycle by applying ISO 13485, ISO 14971, and FDA design control principles to ensure compliance.

· Serve as a Subject Matter Expert and own Risk Management (Hazards Analysis and FMEAs) across the assigned product / product families (mainly complex electro-mechanical devices).

· Support design verification, validation, and reliability testing.

· Participate in supplier qualifications.

· Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements, supporting design transfer activities.

· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

· Support audits, CAPA investigations, and continuous improvement initiatives.
Must Haves / Minimum Requirements
· Detailed knowledge of FDA 21CFR 820, GMP, MDD and EU-MDR, and ISO 13485 and ISO 14971.

· Engineering and technical experience and demonstrated use of Quality tools/methodologies.

· Experience with planning and executing design verification testing, test method development and test method validation (hands on execution experience preferred)

· Ability to author technical reports, business correspondence and standard operating procedures.

· Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring of Master Validation Plans and Reports.
Good to Haves
· Working knowledge of IEC 62304 and IEC 60601-1.

· Ability to drive process improvement activities.

· ASQ Certification in Quality or Reliability.

· Ability to multi-task, prioritize, meets/exceed deadlines and holds themselves, and others accountable.
Educational Requirements
Bachelor’s degree in engineering or science with 5+ years of work experience in Quality and/or Engineering OR master’s degree in engineering or science with 3+ years of work experience in Quality and/or Engineering